Joint partners forum for strengthening and aligning tb diagnosis and treatment

Introduction and access to new drugs under the Global Fund’s new funding model

Mohammed Yassin (The Global Fund)

Dr. Yassin presented the challenges and opportunities relating to scale up of DR−TB services. The Global Fund has supported the expansion of PMDT services with increasing allocations of funds. The number of MDR-TB cases treated by Global Fund-supported programmes increased from 64,000 in 2012 to 150,000 in 2014. Global Fund grants have also supported the procurement of over 2’000 GeneXpert machines and 2 million cartridges in 2013-14. GF looks to countries having a balance between basic TB and DR-TB services, with close alignment in the scale up of diagnostic services with those for the management of the detected cases. Global Fund support is contributing to the change in the mode of MDR-TB treatment – including catalysing “reform” and scale-up of ambulatory treatment, and the leveraging of additional resources. The Global Fund supports the introduction of new drugs and shorter regimens for MDR-TB, along with support to build capacity for active pharmacovigilance and other required areas in accordance with WHO recommendations. For example 15 countries have included funding requests for the treatment of pre-XDR and XDR-TB cases, including the use of bedaquiline. The funding requested is for 2,000 cases, establishing/strengthening active pharmacovigilance, and the provision of the required technical assistance (TA) and capacity building. With the creation of the bedaquiline donation programme between USAID and Janssen, countries can re-programme any funding allocated for bedaquiline to support PMDT activities and scale-up treatment depending on need and priorities. GF support allows countries to receive technical assistance through the regional GLCs. The previous GLC memorandum of understanding between Global Fund and WHO, is to be revised and extended. The aim of the new agreement will be: to contribute to overall TB and DR-TB control; disbursement of funds will be performance-based and services quality assured; strengthen coordination and collaboration between WHO, USAID, STP/GDF; and support the introduction of new diagnostics and new drugs. Consultations are ongoing with a wide range of TB partners on the best options for future TA for PMDT and align with End TB Strategy, Global Stop TB Plan and the new Global Fund Strategy Stop TB / GDF Access Strategies and Support for New Drugs Uptake

Joel Keravec (GDF, Stop TB Partnership)

Dr Keravec stressed that the key issues and access challenges for new drug introduction should be addressed by a Supply Chain Management (SCM) systemic approach. Key interventions are required to support a rational uptake strategy and a framework for early adoption, with dedicated strategies for introduction, implementation and monitoring are important. New drugs (e.g. Bdq & Dlm) will be distributed along with existing SLDs. There is therefore the opportunity to build on existing systems & tools and further improve access and SCM initiatives, such as GDF Strategic Rotating Stockpile, MDR-TB costs decreases, as well as   Technical assistance tools like QuanTB to support proper introduction and build on on-going Harmonized regional registration initiatives to address the regulatory issues, However countries' procurement systems and SCM models are different. Hence a “one fits all strategy” is not appropriate, rather more appropriate are market−based and country-clusters specific approaches, in line with key elements of WHO recommended implementation package for new drugs introduction and Stop TB partnership advocacy framework.

Discussion, Q&A:

The meeting was informed that over 100 patients are being treated with Bdq via NTP in South Africa. However whether South Africa can access Bdq via the donation program is still being discussed. Also during the discussions, questions from the audience highlighted the urgent need for having a DST to the new drugs available. An update of the current work was provided by Daniella Cirillo, from which it appears that a standardised method for Bdq and Dlm susceptibility testing may be available by the end of 2015.

The major focus of the discussions was on the "call for action" from MSF and the other 88 co− signatories, albeit with the exciting announcement from Otsuka on their plans for making Dlm available. A major concern raised in relation to the call was of the need to avoid overlap of platforms, particularly as there may be competition for the same space. It was stressed that duplication of actions and confusion needs to be avoided at all costs. t was clarified by those who signed the "call for action" that its objective was not to establish any new platform, and that they also want to avoid duplication of structures and efforts. Rather if appropriate, the activities called for should be done within existing structures, but there is a need for faster action. The desire is to bring all the relevant players together in order that they collaborate and communicate better, and wider access to the new drugs is achieved quickly. A suggestion was that the GDI, with its Task Force structure, could provide the most appropriate "house" for this activity, and that the "call for action" would bring a real sense of focus and purpose of intent with it. It was agreed that this discussion would be taken forwards during an open session of the meeting of the GDI Core Group on the morning of Friday 1 May 2015. A number of country representatives stressed that the slow uptake of the new drugs by countries was not just related to financing, but often related to the numerous approval hurdles that had to be overcome. Hence in addition to the extra resources and TA (in which the rGLCs have an important role to play) needed for the introduction of new drugs and scale up of PMDT services generally within countries, what is needed is stronger advocacy rather than the establishment of yet another global process or mechanism.